510(k) · Cleared
ClearedImmulite 2000 Afp, BR-MA, and OM-MA Calibration Verification Material
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Siemens Healthcare Diagnostics, Inc. · JJX Single (Specified) Analyte Controls (Assayed And Unassayed)
Cleared on Jan 14, 2014 as substantially equivalent to K102086 (Roche Diagnostics, 2010) and 2 other predicates after a 133-day review. Its family tree reaches back 7 generations to 2000.
- Decided
- Jan 14, 2014
- Review
- 133 days
- Class
- Class I
- Product code
- JJX
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 7 generations to K001015 (2000). 13 ancestors in all, the oldest K993210 (2000). No later device cites it as a predicate yet.
- Root · 7 generations backK001015 Elecsys Thyroglobulin CalcheckRoche Diagnostics Corp. · 2000
- 6 generations backK020883 Elecsys Probnp CalcheckRoche Diagnostics Corp. · 2002
- 5 generations backK031698 Elecys SHBG CalcheckRoche Diagnostics Corp. · 2003
- 4 generations backK040157 Elecsys C-Peptide CalcheckRoche Diagnostics Corp. · 2004
- 3 generations backK051185 Elecsys CA 19-9 CalcheckRoche Diagnostics Corp. · 2005
- 2 generations backK101365 Elecsys CA 19-9 Calcheck 5Roche Diagnostics Corp. · 2010
- 1 generation backK122242 Elecsys CA 15-3 II Calcheck 5Roche Diagnostics · 2012
- This deviceK132739 Immulite 2000 Afp, BR-MA, and OM-MA Calibration Verification MaterialSiemens Healthcare Diagnostics, Inc. · 2014
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K001015 | Elecsys Thyroglobulin Calcheck | Roche Diagnostics Corp. | 2000 | — |
| −6 | K020883 | Elecsys Probnp Calcheck | Roche Diagnostics Corp. | 2002 | — |
| −5 | K031698 | Elecys SHBG Calcheck | Roche Diagnostics Corp. | 2003 | — |
| −4 | K040157 | Elecsys C-Peptide Calcheck | Roche Diagnostics Corp. | 2004 | — |
| −3 | K051185 | Elecsys CA 19-9 Calcheck | Roche Diagnostics Corp. | 2005 | — |
| −2 | K101365 | Elecsys CA 19-9 Calcheck 5 | Roche Diagnostics Corp. | 2010 | — |
| −1 | K122242 | Elecsys CA 15-3 II Calcheck 5 | Roche Diagnostics | 2012 | — |
| 0 (this device) | K132739 | Immulite 2000 Afp, BR-MA, and OM-MA Calibration Verification Material | Siemens Healthcare Diagnostics, Inc. | 2014 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
| 2001 | 1 | 0 |
| 2010 | 2 | 0 |
| 2011 | 1 | 0 |
| 2013 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in JJX? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against? (3)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K102086 | Elecsys CA 125 II Calcheck 5Summary page 1…Panel: Clinical Chemistry (75) 3. Predicate Device Name Elecsys CA 125 11 CalCheck 5 Predicate 510(k) No: K102086 4. Device Description: The Calibration Verification Material (CVM) contains one set of… | 2010 |
| * | K122242 | Elecsys CA 15-3 II Calcheck 5Summary page 5…Panel: Clinical Chemistry (75) 3. Predicate Device Name Elecsys CA 15-3 11 CalCheck 5 Predicate 510(k) No: K 122242 4. Device Description: The Calibration Verification Material (CVM) contains one set of four vial… | 2012 |
| * | K122534 | Immulite 1000 Third Generation Psa Calibration Verification MaterialSummary page 9…Clinical Chemistry (75) 3. Predicate Device Name IMMULITE/IMMULITE 1000 Third Generation PSA CVM Predicate 510(k) No: K122534 4. Device Description: The Calibration Verification Material (CVM) contains One set of… | 2013 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 14 years and passes through 3 companies; a new generation was cleared every 1.4 years on median.
- None of the 13 ancestors has a recall.
- 1 other device also cites its predicate K102086.
How does its category compare?
All JJX devicesJJX Single (Specified) Analyte Controls (Assayed And Unassayed): FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, this device’s year, is highlighted.
FDA decisions per year · JJX
2in 2017
2026 to Oct 25, outlined.
Median 510(k) review, days · JJX
31in 2016
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · JJX
1in 2021
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JJX
22in 2025
MAUDE reports naming product code JJX, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 6 | 53 | 3 | 2 |
| 2008 | 8 | 52 | 3 | 0 |
| 2009 | 17 | 80 | 0 | 1 |
| 2010 | 24 | 80 | 3 | 6 |
| 2011 | 19 | 62 | 2 | 62 |
| 2012 | 15 | 40 | 0 | 32 |
| 2013 | 19 | 37 | 0 | 51 |
| 2014 | 22 | 30 | 1 | 48 |
| 2015 | 11 | 65 | 1 | 67 |
| 2016 | 6 | 31 | 2 | 37 |
| 2017 | 2 | — | 0 | 19 |
| 2018 | 0 | — | 2 | 35 |
| 2019 | 0 | — | 0 | 82 |
| 2020 | 0 | — | 0 | 77 |
| 2021 | 0 | — | 1 | 43 |
| 2022 | 0 | — | 0 | 24 |
| 2023 | 0 | — | 0 | 22 |
| 2024 | 0 | — | 0 | 30 |
| 2025 | 0 | — | 0 | 22 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The IMMULITE® 2000 AFP Calibration Verification Material (CVM) is intended for monitoring system performance of the IMMULITE Immunoassay system for the quantitative measurement of AFP antigen.
The IMMULITE® BR-MA Calibration Verification Material (CVM) is for in vitro diagnostic use in the verification of calibration and reportable range of the IMMULITE BR-MA assay on the IMMULITE 2000 systems
The IMMULITE® OM-MA Calibration Verification Material (CVM) is for in vitro diagnostic use in the verification of calibration and reportable range of the IMMULITE OM-MA assay on the IMMULITE 2000 systems
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K132739 · printed Nov 6, 2026
Cite this page
510(k) Report. “K132739: Immulite 2000 Afp, BR-MA, and OM-MA Calibration Verification Material.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K132739
Report an extraction error
Are you the manufacturer?
Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026